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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cyproheptadine as an appetite stimulant in patients with cystic fibrosis and your effect on gain weight
Scientific title
A randomized, double-blind, placebo-controlled trial cyproheptadine versus a placebo for appetite stimulation in patients with cystic fibrosis
Secondary ID [1] 253468 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 261021 0
Malnutrition 261043 0
Condition category
Condition code
Human Genetics and Inherited Disorders 259160 259160 0 0
Cystic fibrosis
Diet and Nutrition 259183 259183 0 0
Other diet and nutrition disorders
Respiratory 259242 259242 0 0
Other respiratory disorders / diseases

Study type
Description of intervention(s) / exposure
The intervention group will receive cyproheptadine for a period of 12 weeks and the control group will receive placebo for the same period.
In the first week 2mg three times a day
In the next weeks 4mg three times daily

Mode of administration: Syrup with a concentration of 1 ml

The patient gets two bottles:
In the first week, in the intervention group
taking the syrup, where each ml is the concentration of 2 mg of cyproheptadine.
In the rest week, the intervention group takes the syrup has a concentration of 4 mg per ml.
Intervention code [1] 257928 0
Treatment: Drugs
Comparator / control treatment
The control group will syrups with taste and appearance similar to cyproheptadine, but will be placebo.
Control group

Primary outcome [1] 262035 0
Weight gain in patients with cystic fibrosis
Timepoint [1] 262035 0
The result will be evaluated by the measurement of weight, height and arm circumference of the skinfolds. Results are expressed as z score and percentile
Secondary outcome [1] 268955 0
To compare the food consumption and nutritional status of patients with cystic fibrosis before and after the intervention, in the intervention and control groups
Timepoint [1] 268955 0
Food consumption is measured by food frequency questionnaire
Secondary outcome [2] 268956 0
Correlate food intake pulmonary function and with nutritional status
Timepoint [2] 268956 0
Will compare the spirometry performed on the first day of treatment and after the twelve weeks

Key inclusion criteria
* patients aged between 5 and 18 years;
* qualified to spirometry;
* weight / age <100%.
Minimum age
5 Years
Maximum age
18 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Patients with intolerance to antihistamines, patients using sedative or narcotic drugs, patients that have taken appetite stimulants or steroids for 30 days before the study, inability to do spirometry.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The pharmaceutical patients randomized in blocks by Pepi software, to receive placebo or cyproheptadine The researcher who delivered the envelopes to the patients, had no knowledge of its contents because the allocation was concealed in sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 3157 0
State/province [1] 3157 0
Rio Grande do Sul

Funding & Sponsors
Funding source category [1] 258386 0
Name [1] 258386 0
Pontificia Universidade Catolica do Rio Grande do Sul
Address [1] 258386 0
Instituto de Pesquisas Biomedicas - IPB
Hospital Sao Lucas
Av Ipiranga, 6690 - 2 andar
Caixa Postal 1429
Porto Alegre - RS - Brasil
CEP 90610-000
Country [1] 258386 0
Primary sponsor type
Regina Nejedlo
Rua Mostardeiro, 455
Loja 07
Independencia, Porto Alegre / RS
Cep: 90430-001
Secondary sponsor category [1] 257542 0
Name [1] 257542 0
Pontificia Universidade Catolica do Rio Grande do Sul
Address [1] 257542 0
Instituto de Pesquisas Biomedicas - IPB
Hospital Sao Lucas
Av Ipiranga, 6690 - 2 andar
Caixa Postal 1429
Porto Alegre - RS - Brasil
CEP 90610-000
Country [1] 257542 0

Ethics approval
Ethics application status
Ethics committee name [1] 260361 0
Comite de Etica do Hospital Sao Lucas da PUCRS
Ethics committee address [1] 260361 0
Av. Ipiranga 6690
Predio 60 - Sala 314
Porto Alegre - RS - Brasil
CEP 90610-900
Ethics committee country [1] 260361 0
Date submitted for ethics approval [1] 260361 0
Approval date [1] 260361 0
Ethics approval number [1] 260361 0
Ethics committee name [2] 260363 0
Comite de Etica da Irmandade Santa Casa de Misericordia
Ethics committee address [2] 260363 0
Rua Prof. Annes Dias, 295
Cep: 90020-090
Porto Alegre -RS - Brasil
Ethics committee country [2] 260363 0
Date submitted for ethics approval [2] 260363 0
Approval date [2] 260363 0
Ethics approval number [2] 260363 0

Brief summary
The purpose of this study was to determine whether the administration of Cyproheptadine (CH) was able to induces weight gain, improving food consumption and pulmonary function in patients with cystic fibrosis (CF).
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 32130 0
Address 32130 0
Country 32130 0
Phone 32130 0
Fax 32130 0
Email 32130 0
Contact person for public queries
Name 15377 0
Larissa da Rosa Feix
Address 15377 0
Faculdade de Medicina da PUCRS
Instituto de Pesquisas Biomedicas - IPB
Hospital Sao Lucas
Av Ipiranga, 6690 - 2 andar
Caixa Postal 1429
Porto Alegre - RS - Brasil
Cep: 90610-000
Country 15377 0
Phone 15377 0
+55 (51) 9192.8811
Fax 15377 0
Email 15377 0
Contact person for scientific queries
Name 6305 0
Renato Tetelbom Stein
Address 6305 0
Instituto de Pesquisas Biomedicas - IPB
Hospital Sao Lucas
Av Ipiranga, 6690 - 2 andar
Caixa Postal 1429
Porto Alegre - RS - Brasil
Cep: 90610-000
Country 6305 0
Phone 6305 0
+55 (51) 9972.6224
Fax 6305 0
Email 6305 0

No information has been provided regarding IPD availability
Summary results
No Results